Controlled Human Infection Studies: Proposals for guidance on how to design, develop and produce a challenge strain
Isabelle Bekeredjian-Ding1, Jean-Hugues Trouvin2, Hilde Depraetere3, Carine La4, Akamol E. Suvarnapunya5, Alan Bell4, Alex Mann4, Pauline Meij6, Jeffrey M. Bethony7, Linda Schellhaas7, Winfred Badanga Nazziwa8, Eric Karikari-Boateng9, Jetsumon Sattabongkot Prachumsri10, Paula Salmikangas11, Dean Smith12, Peter Stjärnkvist13, Wim Van Molle14, Marc Baay15, Pieter Neels2
1Division of Microbiology, Paul-Ehrlich Institute, Langen, Germany
2International Alliance for Biological Standardization – IABS, Geneva, Switzerland
3European Vaccine Initiative, Heidelberg, Germany
4HVIVO, London, UK
5Department of Diarrheal Disease Research, Bacterial Disease Branch, Walter Reed Army Institute of Research, Silver Spring, MD, USA
6Center for Cell and Gene Therapy, Interdivisional GMP Facility, Leiden University Medical Center, Leiden, the Netherlands
7NaL3 Production Unit, Department of Microbiology, Immunology and Tropical Medicine, The George Washington University, Washington DC, USA
8Uganda National Council for Science & Technology, Kampala, Uganda
9Food and Drugs Authority Ghana, Accra, Ghana
10Mahidol Vivax Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand
11NDA Advisory Board, Sweden
12Health Canada, Canada
13Medical Product Agency Sweden, Sweden
14Sciensano, Brussels, Belgium
15P95 Epidemiology & Pharmacovigilance, Leuven, Belgium
Tài liệu tham khảo
Thông tin
Thông tin xuất bản
Biologicals
Tập 74
16-23
Thông tin tác giả